Vardenafil for Treatment of Men With Erectile Dysfunction: Efficacy and Safety in a Randomized, Double‐Blind, Placebo‐Controlled Trial

Erectile dysfunction (ED) has been reported to affect as many as 20 to 30 million men in the United States and 152 million men worldwide (NIH Consensus Conference, 1993;Feldman et al, 1994;Ayta et al, 1999).The risk for ED increases progressively with advancing age (Feldman et al, 1994).The causes of ED are divided into 3 broad categories: psychogenic, organic, and mixed (Lue, 2000).Although psychogenic factors are involved alone or in combination with organic causes in a substantial number of ED cases (Araujo et al, 1998;Rosen, 2001), organic factors are thought to be involved in the vast majority of ED cases (Levine, 2000).Organic ED results from neurologic, hormonal, or vascular pathologies and may often have drug-related causes (Lue, 2000).ED is commonly associated with a number of other conditions frequently occurring in aging men, including prostatic hypertrophy, arterial hypertension, ischemic heart disease, peripheral vascular disease, atherosclerosis, hyperlipidemia, and diabetes mellitus (Chew et al, 2000;Goldstein, 2000;Lue, 2000).